Clinical Trial

Different-Dose SCRT Plus CAPOX, PD-1 Blockade and IL-2 in LARC

Study acronym: PRIDE-02
Recruiting Phase 2
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Summary
This prospective, randomized phase II trial is designed to evaluate whether low-dose short-course radiotherapy differs from common-dose short-course radiotherapy in terms of efficacy when both regimens are sequentially combined with CAPOX, a PD-1 monoclonal antibody, and interleukin-2 (IL-2) in patients with locally advanced rectal cancer. The study is based on findings from our previous single-center, single-arm PRIDE01 study, in which neoadjuvant short-course radiotherapy followed by systemic chemoimmunotherapy and IL-2 demonstrated encouraging antitumor activity relative to historical short-course radiotherapy-based approaches. The current trial aims to provide more robust clinical evidence regarding the potential role of low-dose radiotherapy combined with IL-2 as a sensitization strategy in multimodal neoadjuvant therapy. By comparing complete response rates between the two radiotherapy dose levels, this study may help define an optimized neoadjuvant approach and support future organ-preservation strategies for patients with locally advanced rectal cancer.
Trial Details
NCT Number NCT07646639
Lead Sponsor The First Affiliated Hospital with Nanjing Medical University
Conditions Rectal Cancer, Radiotherapy
Enrollment 122 participants
Start Date 2026-05-20
Primary Completion 2028-12-31 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-15